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Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

Primary Purpose

Solid Tumors, Non-Hodgkin Lymphoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ADG106

About this trial

This is an interventional treatment trial for Solid Tumors, Non-Hodgkin Lymphoma focused on measuring Solid tumor, Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Male or female, 18 years of age or older at the time of consent.
Provide written informed consent.
Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies.
Life expectancy of 12 weeks or greater.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma.
Adequate organ and bone marrow function
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration.

Exclusion Criteria

Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
Any active autoimmune disease or documented history of autoimmune disease.
Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following:
History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis, drug-related or auto-immune hepatitis).
History of clinically significant cardiac disease.
Uncontrolled current illness.

8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy.

9. Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer.

14. Subjects who got either below treatment:

Any previous anti-CD137 mAb (eg, utomilumab, urelumab) treatment.
Subject who has received allogenic hematopoietic stem cell transplant or autologous stem cell transplanted.

Sites / Locations

Horizon Oncology Research
NEXT Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADG106 Dose escalation

Arm Description

Outcomes

Primary Outcome Measures

Number of participants experiencing dose-limiting toxicities

Number of participants experiencing clinical and laboratory adverse events (AEs)

Secondary Outcome Measures

The area under the curve (AUC) of plasma concentration of drug

Maximum concentration (Cmax)

Time at which maximum concentration (Tmax)

Lowest plasma concentration (C[trough])

Full Information

NCT ID

NCT03707093

First Posted

October 8, 2018

Last Updated

October 15, 2022

Sponsor

Adagene Inc

1. Study Identification

Unique Protocol Identification Number

NCT03707093

Brief Title

Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

Official Title

A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

September 17, 2018 (Actual)

Primary Completion Date

January 24, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adagene Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells. The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives To characterize the pharmacokinetic (PK) profiles of ADG106 To evaluate the immunogenicity of ADG106 To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Solid Tumors, Non-Hodgkin Lymphoma

Keywords

Solid tumor, Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADG106 Dose escalation

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ADG106

Intervention Description

IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment.

Primary Outcome Measure Information:

Title

Number of participants experiencing dose-limiting toxicities

Time Frame

2 Cycles (42 days)

Title

Number of participants experiencing clinical and laboratory adverse events (AEs)

Time Frame

First dose to 28 days post last dose

Secondary Outcome Measure Information:

Title

The area under the curve (AUC) of plasma concentration of drug

Time Frame

From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

Title

Maximum concentration (Cmax)

Time Frame

From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

Title

Time at which maximum concentration (Tmax)

Time Frame

From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

Title

Lowest plasma concentration (C[trough])

Time Frame

From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male or female, 18 years of age or older at the time of consent. Provide written informed consent. Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies. Life expectancy of 12 weeks or greater. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma. Adequate organ and bone marrow function Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration. Exclusion Criteria Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis. Any active autoimmune disease or documented history of autoimmune disease. Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following: History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis, drug-related or auto-immune hepatitis). History of clinically significant cardiac disease. Uncontrolled current illness. 8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy. 9. Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer. 14. Subjects who got either below treatment: Any previous anti-CD137 mAb (eg, utomilumab, urelumab) treatment. Subject who has received allogenic hematopoietic stem cell transplant or autologous stem cell transplanted.

Facility Information:

Facility Name

Horizon Oncology Research

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

NEXT Oncology

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

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